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Model Number 466P306X |
Device Problems
Fracture (1260); Failure to Align (2522)
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Patient Problem
Perforation (2001)
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Event Date 10/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused fracture, tilt and perforation of multiple filter struts beyond the wall of the inferior vena cava (ivc).The indication for the filter placement, procedural details and medical history have not been provided and there is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Ivc filter tilt has been associated operator technique and/or vessel anatomy, specifically asymmetry and tortuosity.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or post implant images for review the reported event(s) could not be confirmed or further clarified.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
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Event Description
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As reported by the legal team, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, fracture tilt and perforation of multiple filter struts beyond the wall of the ivc.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering.And other damages.
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Search Alerts/Recalls
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